Objective: To evaluate the therapeutic effects of entecavir (ETV) and interferon-α (IFN-α) treatments for 48 weeks for chronic hepatitis B (CHB) in patients with different baseline alanine aminotransferase (ALT) levels.
Methods: We retrospectively analyzed the data of 369 CHB patients receiving ETV and IFN-α treatments for 48 weeks. We compared the virological response rates, HBsAg clearance, and HBsAg reduction between the patients receiving ETV and IFN-α treatments with different baseline ALT levels[≤ 5×upper limits of normal (ULN) level (subgroup 1), 5-10×ULN (subgroup 2), and > 10× ULN (subgroup 3)].
Results: In patients receiving ETV treatment, the virological response rate was 83.3% in subgroup 1, 91.4% in subgroup 2, and 95.5% in subgroup 3, as compared with 19.7%, 40%, and 42.9% in the 3 subgroups with IFN-α treatment, respectively, showing significantly differences both among different subgroups with the same treatment and between the same subgroup with different treatments (P < 0.05). HBeAg clearance rates in the 3 subgroups were 8.3%, 16.7% and 35.5% in patients with ETV treatment and were 1.8%, 41.9%, and 38.1% in patients with IFN-α treatment, respectively, showing significant differences among the 3 subgroups with the same treatment (P < 0.05); in the same subgroups with different treatments, the rates differed significantly only between subgroups 2 (P < 0.05). In ETV group, the rate of HBsAg reduction to below 200 IU/ml was 2.5% in subgroup 1 and 13.8% in subgroup 2, showing no significant difference between the two subgroups; in IFN-α group, the rates were also similar between subgroups 1 and 2 (30.6% vs 33.3%, P > 0.05); but the rates differed significantly between the same subgroups with different treatments (P < 0.05).
Conclusions: In all the subgroups with different baseline ALT levels, ETV treatment for 48 weeks results in significantly higher virological response rates than IFN-α treatment in patients with CHB. In patients with a baseline ALT of 5-10 ×ULN, IFN-α can result in a higher HBeAg clearance rate than ETV. In patients with comparable baseline ALT level, IFN-α more effectively reduces HBsAg level than ETV. The patients with a relatively high baseline ALT level (> 5 × ULN) show better responses to both ETV and IFN-α treatment than those with ALT level below 5×ULN. We thus recommend IFN-α for patients with a baseline ALT of 5-10×ULN and ETV for patients with a baseline ALT either below 5 × ULN or beyond 10×ULN.
目的: 分析恩替卡韦与α干扰素在不同基线丙氨酸氨基转移酶（ALT）水平治疗48周后的疗效，为临床慢性乙型肝炎（CHB）抗病毒治疗提供参考依据。
方法: 回顾性分析369例CHB患者的资料，根据治疗方案及基线ALT水平分组，分析治疗48周后不同治疗方案、不同基线ALT水平的病毒学应答率、HBeAg转阴率、HBsAg下降情况，评估治疗效果。
结果: ① 病毒学应答情况：治疗48周后恩替卡韦组在基线ALT ≤ 5倍正常值上限（ULN）（组1）、5~10×ULN（组2）、 > 10×ULN（组3）的病毒学应答率分别为83.3%、91.4%、95.5%，α干扰素组则分别为19.7%，40%，42.9%，不同治疗方案之间及不同ALT水平组之间对比差异均有统计学意义（P < 0.05）。②HBeAg转阴情况：恩替卡韦组的组1、组2、组3在治疗48周后的HBeAg转阴率分别为8.3%、16.7%、35.5%，而α干扰素组分别为1.8%、41.9%、38.1%，对比同一治疗方案不同ALT分组，差异具有统计学意义（P < 0.05），而分析同一ALT分组不同治疗方案，仅在组2中两种治疗方案的HBeAg转阴率差异有统计学意义（P < 0.05）。③HBsAg下降情况：恩替卡韦组在基线ALT ≤ 5×ULN组和 > 5×ULN组的HBsAg小于200 U/mL率分别为2.5%、13.8%，两者差异无统计学意义，α干扰素组则分别为30.6%、33.3%，差异无统计学意义（P > 0.05），而同一ALT分组两种治疗方案的HBsAg小于200 U/mL率的差异均具有统计学意义（P < 0.05）。
结论: 治疗48周后，恩替卡韦组在各个ALT组均较α干扰素组有更高的病毒学应答率。在基线ALT5~10×ULN组中，α干扰素组的HBeAg转阴率高于恩替卡韦组。对于HBsAg下降情况，α干扰素组在各个ALT组均较恩替卡韦组有更好的效果，而同一治疗方案不同ALT组中，基线高ALT水平（ALT > 5×ULN）组的疗效均优于基线低ALT水平（ALT ≤ 5×ULN）组。因此，建议基线ALT水平在5~10×ULN的患者优先选择α干扰素治疗，而基线ALT水平≤ 5×ULN、 > 10×ULN的患者选用恩替卡韦治疗。
Keywords: alanine aminotransferase; chronic hepatitis B; entecavir; interferon-α.